Breathwork for Chronic Musculoskeletal Pain

NCT06455839 | Completed

• 1 other identifier: 00005048
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This project is a single-site, single-arm, clinical feasibility trial examining the impact of a single-session, 2-hour connected consciousness breathing with breath retention (CCBR) training for chronic musculoskeletal pain.

Conditions

Pain; Chronic Pain; Pain, Chronic; Musculoskeletal Pain

Outcome Measures

Primary Outcomes (3)

• Number of Participants with Chronic Pain Recruited

  Examine recruitment rates during the 1 week of recruitment.

  1 week

• Intervention Adherence

  Examine the percentage of participants completing their 2-hour intervention session.

  2 Hours

• Treatment Acceptability

  Treatment acceptability will be assessed with a 12-item adaptation of the Treatment Framework of Acceptability questionnaire. Scores range from 5 to 45. Higher scores reflect greater acceptability.

  Completed immediately after the 2-hour GRMT training

Secondary Outcomes (1)

• Global Impression of Change

  Completed at 2- and 6-week follow-ups

Other Outcomes (12)

• Acute Pain Unpleasantness

  Will be completed immediately before and after the 2-hour intervention session

• Acute Pain Intensity

  Will be completed immediately before and after the 2-hour intervention session

• Daily Pain Intensity

  Daily for 6 weeks

Study Arms (1)

Guided Respiration Mindfulness Therapy

EXPERIMENTAL

Behavioral: Guided Resipiration Mindfulness Therapy (GRMT)

Interventions

Guided Resipiration Mindfulness Therapy (GRMT) BEHAVIORAL

GRMT provides training in respiratory regulation, mindfulness and relaxation. The GRMT training will begin with a 15-minute introduction to the treatment model, followed by an hour of therapist-guided respiration (i.e., continuous rhythmic expansion of the chest, and relaxed exhalation involving release of all respiratory and peripheral musculature). The final 45 minutes will be used to discuss participant experiences during the GRMT training. GRMT training sessions will occur in-person and in a small group format (\<5 participants each).

Guided Respiration Mindfulness Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• having received a professional diagnosis of clinical levels of chronic pain
• being able to not commit to another (new) treatment during the course of the study
• understanding English instructions fluently
• Being 18 and above

You may not qualify if:

• having learned to practice breathwork any time in the past
• being unable to perform most basic tasks due to pain or pain treatment.

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Brian Science and Symptom Management Center

Tallahassee, Florida, 32310, United States

Location

MeSH Terms

Conditions

Pain; Chronic Pain; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 12, 2024
• Study Start: May 29, 2024
• Primary Completion: June 11, 2024
• Study Completion: July 27, 2024
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)